1. Field of the Invention
This invention relates to an improved treatment of illness brought about by hormonal deficiency disease. More particularly, the invention is directed to the simultaneous but separate supply of substances deficient to the liver, and to peripheral body organs and tissue. Specifically, this invention is directed to the whole person treatment of diabetes Mellitus. A chemically structured targeted delivery system to the hepatocyte of the liver supplies the liver with insulin but not to the peripheral system. A separate and substantially simultaneous supply of regular free insulin which is not targeted to the liver supplies the peripheral body needs. The combination of the directed insulin and the free insulin enables a far lower dosage and better control.
2. Background Art
Diabetes Mellitus often occurs early in life by a severe reduction or complete absence of insulin production in the system. This deficiency results in abnormally high levels of glucose in the blood of afflicted patients and an inability of certain tissues to utilize glucose as a nutrient.
Diabetes mellitus is a disease in which the elevated levels of glucose and the inability of the body to metabolize glucose results in eventual death. The more complete the absence of insulin, the more rapid is the death.
The accepted therapy relied on prior to this invention is the subcutaneous administration of insulin. Such treatment while sustaining life, does not correct all biochemical abnormalities. Nor does it prevent the long term sequelae of the disease, which causes microvascular damage resulting in blindness, heart disease, strokes, kidney failure and death.
In this disclosure it is assumed that the patient has a healthy liver capable of proper uptake of glucose and subsequent dispensing of the glucose but for the absence of the regulating hormone insulin.
In the normal warm blooded animal body, intake of a meal triggers production of insulin which is taken up with the digested food and passed through the portal vein to the liver. The insulin is at least partially in control of the liver function in that when proper hormones are present, the liver will convert the glucose from digested food into glycogen and store that glycogen in the liver. Reconversion of glycogen to glucose takes place when blood level sugar is lowered.
It is known to be a fact, but not well understood, that in a normal healthy body, all of the insulin is not taken up by the liver at the time of insulin production. There is a certain quantity of the insulin that bypasses the liver into the peripheral system where it enables the muscle and fat tissue to take up the glucose and employ the glucose in energy production as well as body building.
The teaching of U.S. Pat. Nos. 4,377,567 and 4,603,044 is incorporated herein by reference. U.S. Pat. No. 4,377,567 and U.S. Pat. No. 4,603,044, both address the successful delivery of insulin to the liver by encapsulating the hormone in minute vesicles. The vesicles have target molecules that are recognized by the liver cells. The vesicles are thus taken into the liver for hormone liver function. Although quite successful in obtaining normal liver function, these inventions do not provide the exact mimic of nature in allowing some insulin to escape to the peripheral system. The liver of a healthy system accepts only part of the available insulin, whereas whenever insulin is delivered via the hepatocyte directed vesicles, the entire supply is taken into the liver and now is unavailable for the peripheral system.